12G-SDI cable 8.5M MAJ-2429Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus SDI cable is an 8.5-meter video cable used with a bronchoscope imaging stack to send the picture to a monitor. The 30 reports mostly describe the monitor showing no image at all, or a flickering, noisy, poor-quality picture, plus some connection problems where the cable worked loose. All30 describe malfunctions with no patient involved, and no deaths or injuries were reported. There are no recalls naming this cable.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04953170415630), received between Sep 29, 2023 and Sep 30, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (20 reports).
1 other recall cover devices cleared under the same FDA submission (K222584, K222861); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- No Display/Image20
- Poor Quality Image11
- Erratic or Intermittent Display5
- Disconnection2
- Signal Artifact/Noise2
- Break1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Display/Image
The customer reported that the image output stopped during therapeutic procedure while the patient was under sedation and the device was inside the patient, involving an Olympus serial digital Interface cable. The procedure was completed using an olympus backup device. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944628 ↗MalfunctionSep 8, 2026Erratic or Intermittent Display
The customer reported an image blinking during inspection for use involving an Olympus Serial Digital Interface (SDI) cable. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667024 ↗MalfunctionMay 28, 2026No Display/Image
THE CUSTOMER REPORTED NO IMAGE ON MAIN MONITOR DURING INSPECTION FOR USE INVOLVING AN OLYMPUS SERIAL DIGITAL INTERFACE CABLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25319164 ↗MalfunctionMar 20, 2026Disconnection
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24650517 ↗MalfunctionMar 4, 2026No Display/Image; Poor Quality Image
IT WAS REPORTED THAT WHEN THE SDI CABLE WAS CONNECTED TO THE STACK, THE IMAGE INITIALLY BEGAN FLICKERING WITH GREEN LINES AND THEN WENT BLACK. THE ISSUE OCCURRED DURING PREPARATION FOR USE, AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24510235 ↗MalfunctionMar 3, 2026No Display/Image; Poor Quality Image
IT WAS REPORTED THAT THE MONITOR INITIALLY STARTED FLICKERING WITH GREEN LINES AND THEN WENT BLANK WHEN USED WITH THE SDI CABLE. THIS ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24502984 ↗MalfunctionFeb 20, 2026Erratic or Intermittent Display
IT WAS REPORTED THE SERIAL DIGITAL INTERFACE CABLE PRESENTED A MONITOR WITH A BLINKING IMAGE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24405248 ↗MalfunctionFeb 18, 2026No Display/Image
IT WAS REPORTED THE SERIAL DIGITAL INTERFACE CABLE WAS UNABLE TO GET CONSISTENT IMAGE. THIS ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378864 ↗MalfunctionFeb 6, 2026Disconnection; Poor Quality Image
IT WAS REPORTED THE SERIAL DIGITAL INTERFACE HAD IMAGE NOISE AND DISCONNECTION UNDER THE CONNECTOR DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24275578 ↗MalfunctionFeb 5, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272163 ↗MalfunctionFeb 5, 2026Erratic or Intermittent Display; Poor Quality Image
IT WAS REPORTED THE SERIAL DIGITAL INTERFACE CABLE CAUSED IMAGE NOISE. THE ISSUE WAS FOUND DURING A THERAPEUTIC VIDEO-ASSISTED THORACOSCOPIC SURGERY, AND IT WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24271899 ↗MalfunctionFeb 5, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268348 ↗MalfunctionNov 12, 2025No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CABLE CONNECTED TO THE MONITOR EXHIBITED NOISE AND MOMENTARY BLACKOUTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23537935 ↗MalfunctionSep 19, 2025Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095095 ↗MalfunctionSep 3, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS UNABLE TO SEND AN SDI (SERIAL DIGITAL INTERFACE) SIGNAL DURING SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22952051 ↗MalfunctionAug 27, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE EXPERIENCED MOMENTARY BLACKOUTS DURING A UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22907530 ↗MalfunctionAug 20, 2025No Display/Image; Loose or Intermittent Connection; No Display/Image; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22848664 ↗MalfunctionMay 2, 2025No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD GREEN LINES AND INTERMITTENT BLACK SCREEN ON DISPLAY. THE ISSUE OCCURRED DURING SERVICE / MAINTENANCE (NOT IN A CLINICAL SETTING). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21954113 ↗MalfunctionMar 28, 2025No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NOISE AND NO VIDEO IMAGE. THE ISSUE WAS FOUND DURING SEDATION OF THERAPEUTIC PROCEDURE. IT WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21719118 ↗MalfunctionMar 12, 2025Signal Artifact/Noise; Signal Artifact/Noise
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21585584 ↗MalfunctionJan 16, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE'S CABLE WAS DAMAGED, RESULTING IN GREEN NOISE IN THE IMAGES. THE ISSUE OCCURRED DURING THE PRE-OPERATION INSPECTION, AND THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21167630 ↗MalfunctionJan 16, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE EXPERIENCED A MALFUNCTION DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21167569 ↗MalfunctionDec 2, 2024Poor Quality Image; Poor Quality Image
A FIELD SERVICE ENGINEER REPORTED ON BEHALF OF THE CUSTOMER, THAT THE SERIAL DIGITAL INTERFACE (SDI) CABLE WAS PRODUCING IMAGE NOISE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20818927 ↗MalfunctionOct 24, 2024No Display/Image; No Display/Image
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SERIAL DIGITAL INTERFACE CABLE EXHIBITED AN IMAGE BLACKOUT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20524384 ↗MalfunctionAug 27, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED, THE SERIAL DIGITAL INTERFACE CABLE WAS USED IN A CASE WHERE THERE WAS INTERMITTENT IMAGE. THE ISSUE OCCURRED DURING A THERAPEUTIC LIVER RESECTION PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM AND THE PROCEDURE WAS ABLE TO BE COMPLETED USING THE SAME SET OF EQUIPMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20075274 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K222584, K222861. One submission often covers many models, so check the product and lot details in each record.
- Z-0181-2025 · Aug 21, 2024 · Open, ClassifiedOlympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Other Bronchoscope (Flexible Or Rigid) devices
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls5 deaths1,557 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1 death1,214 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1,146 reports
- Ion 380748Intuitive Surgical, Inc. · Bronchoscope (flexible or rigid)1 recall97 deaths1,278 reports
- VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)1,155 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)5 recalls3 deaths621 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · Bronchoscope (Flexible Or Rigid)3 recalls333 reports
- BRONCHOVIDEOSCOPE BF-1T150Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls212 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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